NCT05537649已完成不适用
Glycemic Responses of an Innovative Oat Porridge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Glucose response
研究概览
简要总结
The aim of this study is to investigate whether enzymatic modification of starch in a food product using amylomaltase induces a lower glycemic response in healthy subjects compared to its unmodified counterpart.
详细描述
A single-blind, randomized, cross-over study design will be applied. During each of the two study visits, healthy participants will consume an oatmeal porridge. One porridge will be treated will amylomaltase to modify the molecular structure of starch while the other porridge will serve as a control (unmodified counterpart). Blood glucose measurements will be taken postprandially at regular time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
- •Fasting whole blood glucose values < 6.3 mmol/L
- •Regular diet with 3 meals a day (at least 5 times a week)
- •Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigators on the basis of medical history
- •Willingness to maintain habitual diet, physical activity pattern, and body weight throughout the trial and refrain from smoking for 12 h prior to each visit
- •Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits.
- •Adequate level of understanding spoken and written English
- •Willingness to provide informed consent to participate in the study
排除标准
- •Failure to meet any one of the inclusion criteria
- •Recent participation in any clinical trial (< 90 days)
- •Pregnant or lactating in the period of the study
- •Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular disease, any pathology (or recent surgical event) of the gastrointestinal system or any current metabolic or endocrine disease
- •Alcohol consumption of > 14 standard drinks for women and > 21 standard drinks for men per week
- •Celiac disease or gluten intolerance
- •Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids the last 4 weeks before the screening visit
- •Use of antibiotics during the last three months
- •Reported slimming or medically prescribed diet
- •Unwillingness or inability to comply with the experimental procedures and to follow the safety guidelines
结局指标
主要结局
Glucose response
时间窗: up to 3 hours
incremental area under the curve of blood glucose after oat porridge consumption
次要结局
- Glucose response(up to 3 hours)
研究者
研究点 (2)
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